WHO needs 'additional clarifications' to approve Covaxin from Bharat Biotech
Bharat Biotech needs to present clarified details to WHO for Covaxin approval in emergency use
The World Health Organization's technical advisory panel has concluded that Bharat Biotech must provide "additional clarifications" before conducting a final "risk-benefit assessment" for Covaxin's emergency use listing.
"The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure," stated WHO in email response.
"The TAG met today (October 26, 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine."
"The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, November 3," stated the Who, in response to an inquiry about the decision to list Covaxin for emergency use.
On April 19, Bharat Biotech, based in Hyderabad, submitted an EOI (Expression of Interest) to the WHO for the vaccine's Emergency Use Listing (EUL).
The WHO said last week that it expects one more piece of information from Bharat Biotech on Covaxin and that it must thoroughly analyse vaccines to verify their safety and that it "cannot cut corners" before approving one for emergency usage.
The timeline for the UN health agency's Emergency Use Listing method is based on how quickly a vaccine manufacturer can supply the data needed for WHO to assess the vaccine's quality, safety, efficacy, and suitability for low- and medium countries.
The Covaxin was found to be effective against symptomatic COVID-19 in 77.8% of cases and 65.2 percent of cases against the novel Delta variant in 65.2 percent of cases. The business announced in June that it has completed the final study of Covaxin effectiveness from Phase 3 studies.
Covaxin from Bharat Biotech, AstraZeneca and Covishield from Oxford University are the two most extensively used vaccines.
Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm have all had their Covid-19 vaccines authorised by the WHO for emergency use.
